Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.

Study Overview

• Status: Unknown
• Conditions: Ketamine Adverse Reaction
• Intervention / Treatment: Drug: Ketamine Hydrochloride

Detailed Description

This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000
      • Recruiting
      • University Kebangsaan Malaysia Medical Center
      • Contact: Zamri Zuhdi, MD; Phone Number: 6019 2436634; Email: zamriz7582@gmail.com
      • Contact: Ian Chik, MD; Phone Number: 0123243404; Email: ianchikmd@gmail.com
      • Principal Investigator: Zamri Zuhdi, MD
      • Principal Investigator: Azlanudin Azman, MD
      • Principal Investigator: Ian Chik, MD
      • Principal Investigator: Norma Mohamad, MD
      • Principal Investigator: Muhammad Hafiz Ismail, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Malaysian citizens of who is able to give valid consent
• Patient planned for ERCP (either emergency or elective)

Exclusion Criteria:

• Known hypersensitivity towards Ketamine or Midazolam
• Patient refusal to participate or unable to give consent
• Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
• Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
• Acute myocardial infarction, acute coronary syndrome (<3 months)
• Tachyarrythmia
• Pregnancy
• IVDU or substance abuse patient
• Patient with history of hallucination
• Child's Pugh Class C

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Midazolam group; Standard sedation for ERCP in UKMMC
EXPERIMENTAL: Ketamine group	Drug: Ketamine Hydrochloride; patient in Ketamine group will be given Ketamine as sedative agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depth of sedation	based on Ramsay Sedation Scale, from a scale of 1-6.; Patient is anxious and agitated or restless, or both; Patient is co-operative, oriented, and tranquil; Patient responds to commands only; Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; Patient exhibits no response The aim of sedation is a score of 3-4	1 hour
completion rate	to evaluate completion rate between Ketamine and Midazolam group	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon satisfaction score	subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent	within 4 hours after completion of ERCP
Patient satisfaction score	subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent	within 4 hours after completion of ERCP
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms	recording the adverse events of each sedation.; Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg; Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg; Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute; Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute; Hypoxia: defined by oxygen saturation less than 95%; Respiratory rate abnormality; Nausea, vomiting, emergence symptoms	24 hours

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Ian Chik, MD, Universiti Kebangsaan Malaysia Medical Centre; Principal Investigator: Norma mohamad, MD, Universiti Kebangsaan Malaysia Medical Centre; Principal Investigator: Zamri Zuhdi, MD, Universiti Kebangsaan Malaysia Medical Centre; Principal Investigator: Azlanudin Azman, MD, Universiti Kebangsaan Malaysia Medical Centre; Principal Investigator: Muhammad Hafiz Ismail, MD, Universiti Kebangsaan Malaysia Medical Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Hukm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes